Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103753
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-02-14
Brief Title:
Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
A Randomized Placebo Controlled Double Blind Trial of the Effect of Combined Therapy With Deferoxamine and Deferiprone on Myocardial Iron in Thalassemia Major Using Cardiovascular Magnetic Resonance
Status:
UNKNOWN
Status Verified Date:
2005-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thalassemia major is a genetic disorder affecting hemoglobin synthesis rendering individuals dependent upon lifelong blood transfusions Consequently iron overload occurs and patients have shortened life expectancy with the most common cause of death being heart failure This trial tests whether the combination of traditional therapy deferoxamine with a newer drug deferiprone will prove more effective in removing cardiac iron than deferoxamine alone
Detailed Description:
Thalassemia Major TM is a hereditary anemia resulting from a single gene defect that results in abnormal red cell production The survival of affected individuals is dependent upon lifelong blood transfusions Unfortunately this causes total body iron overload and 50 of the patients in the UK are dead by the age of 35 Approximately 70 of these deaths result from heart failure which results as a consequence of cardiac iron toxicity
A Cardiovascular Magnetic Resonance CMR technique which exploits the fact that T2 signal decay relates to tissue iron developed at the Royal Brompton Hospital provides a non-invasive and reproducible assessment of cardiac iron CMR therefore provides a very useful method to assess response to new treatments in this condition Using cardiac T2 as a primary endpoint we will investigate whether the oral chelator deferiprone in combination with traditional treatment deferoxamine is superior in removing cardiac iron as compared to deferoxamine alone This trial will provide the first randomized controlled double-blinded evidence for the efficacy of combination treatment in TM
A Cardiovascular Magnetic Resonance CMR technique which exploits the fact that T2 signal decay relates to tissue iron developed at the Royal Brompton Hospital provides a non-invasive and reproducible assessment of cardiac iron CMR therefore provides a very useful method to assess response to new treatments in this condition Using cardiac T2 as a primary endpoint we will investigate whether the oral chelator deferiprone in combination with traditional treatment deferoxamine is superior in removing cardiac iron as compared to deferoxamine alone This trial will provide the first randomized controlled double-blinded evidence for the efficacy of combination treatment in TM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None